Ivoclar Vivadent Recalls Bluephase Style Light Probes Due to Broken Glass Fibers
Ivoclar Vivadent is recalling 241 Bluephase style light probes because a stock check revealed broken glass fibers between the connector and the fiber bundle.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a physical defect (broken glass fibers) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Ivoclar Vivadent, Inc. is recalling 241 units of the Bluephase style Light probe Pin-point 6>2 mm black (Reference # 636 241). This accessory is a pin-point light probe used with dental curing lights for ultraviolet activation during dental procedures. The recall covers all lots of this specific reference number.
The recall was initiated after a stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes. The affected products were distributed nationwide in the United States and in Canada.
Dental professionals and patients should stop using the affected light probes immediately. Consumers should contact Ivoclar Vivadent, Inc. for further instructions on how to return or replace the devices.
The recalled product
- Product
- bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental curing light Ultraviolet activator for polymerization for use during dental curing.
- Manufacturer
- Ivoclar Vivadent, Inc.
- Affected units
- 241
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Reference number 636241
- all lots
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Ivoclar Vivadent, Inc.
See all →- HighDental amalgam powder may not triturate properly, affecting restoration strength
FDA (Devices) · 2024-02-14
- LowIvoclar Vivadent Recalls Heliomolar Refill Due to Inconsistent Material Handling
FDA (Devices) · 2018-02-28
- LowIvoclar Vivadent Recalls Heliomolar Refill Due to Consistency Issues
FDA (Devices) · 2018-02-28
- LowIvoclar Vivadent Recalls Heliomolar Refill Due to Soft and Sticky Consistency
FDA (Devices) · 2018-02-28
- LowIvoclar Vivadent Recalls Heliomolar Refill Due to Consistency Issues
FDA (Devices) · 2018-02-28
Same hazard · broken glass
See all →- High
- HighMultichem control vials break during shipping or thawing due to glass defect
FDA (Devices) · 2023-10-18
- HighMultichem IA Plus and Controls Recalled Due to Broken Glass Vials
FDA (Devices) · 2023-10-18
- HighGlass Vials in Laboratory Control Products Recalled for Breakage Risk
FDA (Devices) · 2023-10-18
- High